|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Institute of Cardiology, Warsaw, Poland |
|---|---|
| Information provided by: | Institute of Cardiology, Warsaw, Poland |
| ClinicalTrials.gov Identifier: | NCT00821353 |
Purpose
Paroxysmal or chronic atrial fibrillation (AF) develops in about 20- 25% of adult patients with hypertrophic cardiomyopathy (HCM) and represents an important complication in the clinical course of the disease, with adverse long-term consequences on functional status and outcome.
Therefore, aggressive therapeutic strategies are indicated to restore and maintain sinus rhythm (SR) in patients with HCM. Nevertheless, pharmacologic prevention of AF recurrence is challenging because of the limited long-term efficacy and potentially hazardous side effects of available treatment options. Currently radiofrequency catheter ablation (RFCA) of AF is successfully used in clinical practice. However, comparison of the efficacy and safety of these two therapeutic options has not been done up till now in randomized manner in this group of patients.
Thus, the aim of the present study is to compare the efficacy and safety of RFCA vs. antiarrhythmic drug therapy in patients with HCM and AF.
| Condition | Intervention | Phase |
|---|---|---|
|
Atrial Fibrillation Hypertrophic Cardiomyopathy |
Procedure: RF catheter ablation Drug: Antiarrhythmic drugs |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Sinus Rhythm Maintenance in Patients With Hypertrophic Cardiomyopathy and Atrial Fibrillation - Randomized Comparison of Antiarrhythmic Therapy vs. Radiofrequency Catheter Ablation (SHAARC) |
| Estimated Enrollment: | 90 |
| Study Start Date: | January 2009 |
| Estimated Study Completion Date: | September 2011 |
| Estimated Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| RFCA: Active Comparator |
Procedure: RF catheter ablation
RF catheter ablation
|
| Drug: Active Comparator |
Drug: Antiarrhythmic drugs
One of AA drugs (preferably Amiodarone) and cardioversion in cases of chronic AF
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Pawel Derejko, MD, PhD | +48 22 3434 326 | pderejko@yahoo.com |
| Contact: Lidia Chojnowska, MD, PhD | +48 22 3434 340 | lchojnowska@ikard.pl |
| Poland | |
| Institute of Cardiology | Recruiting |
| Warsaw, Poland | |
| Contact: Pawel Derejko, MD, PhD + 48 603 33 88 71 pderejko@yahoo.com | |
| Principal Investigator: Pawel Derejko, MD, PhD | |
| Principal Investigator: | Pawel Derejko, MD, PhD | Institute of Cardiology, Warsaw, Poland |
| Principal Investigator: | Lidia Chojnowska, MD, PhD | Institute of Cardiology, Warsaw, Poland |
| Principal Investigator: | Lukasz Szumowski, MD, PhD | Institute of Cardiology, Warsaw, Poland |
| Principal Investigator: | Franciszek Walczak, MD, PhD | Institute of Cardiology, Warsaw, Poland |
More Information
| Responsible Party: | Institute of Cardiology, Warsaw, Poland ( Pawel Derejko M.D. Ph.D. ) |
| Study ID Numbers: | N N402 194635, 1.7/IV/08 |
| Study First Received: | January 11, 2009 |
| Last Updated: | September 30, 2009 |
| ClinicalTrials.gov Identifier: | NCT00821353 History of Changes |
| Health Authority: | Poland: Ministry of Health |
|
Atrial fibrillation Hypertrophic cardiomyopathy RF ablation Antiarrhythmic drugs |
|
Pathological Conditions, Anatomical Heart Diseases Cardiovascular Agents Cardiomyopathies Pharmacologic Actions Heart Valve Diseases Hypertrophy Pathologic Processes |
Aortic Stenosis, Subvalvular Therapeutic Uses Cardiomyopathy, Hypertrophic Cardiovascular Diseases Atrial Fibrillation Anti-Arrhythmia Agents Aortic Valve Stenosis Arrhythmias, Cardiac |